Device product
Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the immunoassay analyzer.
Z-2389-2018
Product summary
- Event
- Event 80008
- Status
- Terminated
- Classification
- Class II
- Quantity
- 347 units
- Official record key
device-enforcement:Z-2389-2018
Official wording
Reason: The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.
Code information: No specific lot codes. This issue affects users of the cobas e 801 module.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.